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FDA 510(k) Application Details - K143051
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K143051
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
THE ARGEN CORPORATION
5855 OBERLIN DRIVE
SAN DIEGO, CA 92121 US
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Contact
Maria Rao
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
10/23/2014
Decision Date
09/16/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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